Table 3.
Characteristics of unexplained anemia subjects at baseline
| Demographic and clinical characteristics | Immediate intervention group (N=9) | Wait list control group (N=10) |
|---|---|---|
| Age at randomization (years) | 78.6±6.1 | 78.5±7.4 |
| Female sex, n (%) | 6 (66.7) | 5 (50.0) |
| Race, n (%) | ||
| White | 3 (33.3) | 6 (60.0) |
| Black or African American | 6 (66.7) | 3 (30.0) |
| Asian | 0 | 1 (10.0) |
| Medical history, n (%) | ||
| Hypertension | 7 (77.8) | 6 (60.0) |
| Diabetes | 2 (22.2) | 5 (50.0) |
| Medications, n (%) | ||
| Acetylsalicylic acid | 4 (44.4) | 8 (80.0) |
| Oral iron at screening | 1 (11.1) | 1 (10.0) |
| Vitamin B12 | 1 (11.1) | 1 (10.0) |
| MoCA score | 25.9 ±2.1 | 24.9 ±2.3 |
| Symptoms of anemia at enrollment, n (%) | ||
| Dizziness | 1 (11.1) | 0 |
| Pallor | 1 (11.1) | 3 (30) |
| Shortness of breath | 3 (33.3) | 1 (10) |
| Fatigue | 7 (77.8) | 5 (50) |
| No symptoms reported | 1 (11.1) | 0 |
| Baseline laboratory values | ||
| Hemoglobin (g/dL) | 11.19 ± 0.64 | 11.30 ±0.80 |
| Hematocrit (%) | 33.77 ± 1.86 | 35.62 ± 2.52 |
| Mean corpuscular volume (fL) | 89.94±6.84 | 92.48 ± 8.09 |
| Red cell distribution width (%) | N=9 14.76±1.31 |
N=9 14.78±0.99 |
| Reticulocyte count, absolute (109/L) | N=7 48.4±13.5 |
N=8 45.2±6.7 |
| Serum iron (mcg/dL) | 55.3±10.2 | 84.5±25.4 |
| Serum ferritin (ng/mL) | 79.1±54.1 | 53.0±26.1 |
| Total iron binding capacity (mcg/dL) | 313.3±49.1 | 321.3±71.7 |
| Transferrin saturation (%) | 17.9±4.0 | 27.4±9.7 |
| Serum erythropoietin (mIU/mL) | ||
| Creatinine (mg/dL) | 1.16±0.19 | 1.27±0.13 |
| eGFR (ml/min/1.73 m2)a | N=4 51.5±7.0 |
N=8 52.0±5.4 |
| eGFR category, n (%) | ||
| 30–59 | 4 (44.4) | 8 (80) |
| ≥ 60 | 5 (55.6) | 2 (20) |
| High-sensitivity C-reactive protein (mg/L) | N=9 4.712±5.258 |
N=8 1.961± 2.210 |
| Geriatric Evaluation Panel | ||
| Physical function | ||
| Baseline 6MWT results (m) | 351.40±67.01 | 344.80±90.30 |
| Baseline 4-m walk speed – usual walking speed (m/s) | N=6 0.736±0.0220 |
N=8 1.020±0.430 |
| Baseline 4-m walk speed – maximum walking speed (m/s) | N=7 1.054±0.224 |
N=8 1.325±0.393 |
| Cognitive function | ||
| Wechsler Test of Adult Reading standard score | N=7 107.6±21.4 |
N=10 100.0±23.6 |
| Trail Making Test Part B, seconds per completed circle | N = 9 6.37±3.18− |
N=6 14.43±14.82 |
| Composite speed of processing Z-score | N=8 0.16±0.97 |
N=10 −0.13±1.06 |
| Composite complex attention/executive processing Z-score | N=9 0.15±0.80 |
N=9 −0.15±1.20 |
| Composite learning and memory Z-score | N=7 0.69±0.67 |
N=10 −0.48±0.92 |
| Frailty, n/N (%) | ||
| Weight loss | 0/7 (0) | 2/9 (22.2) |
| Exhaustion | 1/9 (11.1) | 1/10 (10.0) |
| Low energy | 0/7 (0) | 0/8 (0) |
| Weakness based on grip strength | 1/6 (16.7) | 4/8 (50.0) |
| Slowness based on 4-m walk speed | 2/5 (40) | 1/8 (12.5) |
| Overall frailty score, n/N (%) | ||
| Robust | 1/4 (25) | 3/6 (50) |
| Pre-frail | 3/4 (75) | 2/6 (33.3) |
| Frail | 0/4 (0) | 1/6 (16.7) |
| Quality of life | ||
| Baseline SF-36 physical component summary score | 43.65±6.70 | 48.80±7.87 |
| Baseline FACT-An total score | N=9 147.9±28.7 |
N=8 156.4±23.9 |
There were no significant differences between the groups except serum iron (p=0.006), transferrin saturation (p=0.015), and the composite learning and memory Z-score (p=0.012).
Plus-minus values are mean ± SD (N reported if at least one subject in either treatment group was missing a response for the baseline characteristic).
Abbreviations: MoCA, Montreal Cognitive Assessment; eGFR, estimated glomerular filtration rate; 6MWT, 6-minute walk test; SF-36, 36-Item Short Form Health Survey; FACT-AN, Functional Assessment of Cancer Therapy–Anemia.
a
Results < 60 only.